Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults

• Status: Completed
• Trial end date: 2000-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of giving indinavir and rifabutin at the same time (simultaneously) vs 4 hours apart (staggered) to HIV-positive and HIV-negative adults.

It is important to determine which medications for HIV-associated diseases, such as Mycobacterium avium complex (MAC) disease, can be given safely and effectively with anti-HIV drugs. Indinavir and rifabutin have been given simultaneously in the past with good results. This study seeks to examine if staggering the doses will make the 2 drugs more effective. HIV-negative volunteers are used in this study to examine the effect of rifabutin on indinavir and the effect of staggered rifabutin doses. The effect of rifabutin on the drug activity of indinavir is evaluated in HIV-positive patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Indinavir; Rifabutin

Criteria

Inclusion Criteria

You may be eligible for this study if you:

• Are HIV-positive or HIV-negative.

• Agree to practice abstinence or to use birth control during the study.

Exclusion Criteria

You will not be eligible for this study if you:

• Have an active opportunistic (HIV-associated) disease or other disease requiring medication within 14 days of study entry.

• Have a history of illness that might put you at risk if given either of the study drugs.

• Have had any severe allergies to any substance in the past.

• Have a history of kidney stones.

• Have a medical condition, or problems with use of alcohol or drugs, which would keep you from completing the study.

• Have had tuberculosis and have never been treated for it.

• Are pregnant or breast-feeding.

• Are taking certain medications.